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Compares treatment options for Steroid Refractory GVHD
Official title Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
ClinicalTrials.gov ID: NCT06343792
What this study is testing
What is RLS-0071?
RLS-0071 is an investigational medicine, being studied as a potential treatment for steroid refractory gvhd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female adults or adolescents (\>12 years old).
- Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
- Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
- No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of...
- Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/mL for at least 3 consecutive measurements and...
You likely can't join if
- Has received more than 1 allo-HSCT
- Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
- Previous failure of ruxolitinib treatment
- Uncontrolled GI infection
- Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD
- Chronic GvHD
See the full eligibility criteria
- Male or female adults or adolescents (\>12 years old).
- Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
- Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
- No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.
- Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/mL for at least 3 consecutive measurements and not supported by growth factor supplementation
- Weight ≥40 kg and ≤ 140 kg at screening.
- Has received more than 1 allo-HSCT
- Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
- Previous failure of ruxolitinib treatment
- Uncontrolled GI infection
- Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD
- Chronic GvHD
- Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
- Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT
- Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment.
- Severe organ dysfunction unrelated to underlying aGvHD
- Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)
- Significant liver disease that is unrelated to GvHD
- Severe kidney disease
- Currently breast feeding.
- Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
- Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.
- Active sepsis
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- St Louis, Missouri, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Freiburg im Breisgau, Germany
- Seville, SE, Spain
- Madrid, Spain
- Salamanca, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Atlanta, Georgia, United States; St Louis, Missouri, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.